Executive Summary

THE PROBLEM

HIV (human immunodeficiency virus) infection and injection drug use are major public health problems in the United States today. The focus of this study lies at the interface of these two critical threats to public health.

The epidemiologic data indicate that the HIV epidemic in this country is now clearly driven by infections occurring in the population of injection drug users, their sexual partners, and their offspring. The proportion of new AIDS cases attributed to the exposure category labeled men who have sex with men has declined steadily over the past 13 years (from 74 percent in 1981 to 47 percent in 1993). At the same time, the proportion of cases attributed to injection drug use has steadily increased during the same period (from 12 percent in 1981 to 28 percent in 1993). These trends in AIDS cases reflect the rising injection drug use related infections of several years ago. By now, the spread of HIV among injection drug users, their sexual partners, and their offspring accounts for a major proportion of new HIV infections in the United States and the continuing expansion of the AIDS epidemic.

Note: Documentation for the material in this Executive Summary appears in the body of the report. Moreover, it should be noted that this summary focuses on the core conclusions and recommendations of the report. Additional conclusions and recommendations appear at the end of individual chapters.

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach.
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Preventing HIV Transmission: The Role of Sterile Needles and Bleach
Executive Summary
THE PROBLEM
HIV (human immunodeficiency virus) infection and injection drug use are major public health problems in the United States today. The focus of this study lies at the interface of these two critical threats to public health.
The epidemiologic data indicate that the HIV epidemic in this country is now clearly driven by infections occurring in the population of injection drug users, their sexual partners, and their offspring. The proportion of new AIDS cases attributed to the exposure category labeled men who have sex with men has declined steadily over the past 13 years (from 74 percent in 1981 to 47 percent in 1993). At the same time, the proportion of cases attributed to injection drug use has steadily increased during the same period (from 12 percent in 1981 to 28 percent in 1993). These trends in AIDS cases reflect the rising injection drug use related infections of several years ago. By now, the spread of HIV among injection drug users, their sexual partners, and their offspring accounts for a major proportion of new HIV infections in the United States and the continuing expansion of the AIDS epidemic.
Note: Documentation for the material in this Executive Summary appears in the body of the report. Moreover, it should be noted that this summary focuses on the core conclusions and recommendations of the report. Additional conclusions and recommendations appear at the end of individual chapters.

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach
The main factor associated with HIV infection among injection drug users is the practice of sharing injection equipment. This multiperson use of syringes is particularly dangerous because residual blood retained in the syringe from one person can be unintentionally and, even with rinsing, inconspicuously passed along to the next person using the syringe. This sharing behavior is in part a consequence of the restricted availability of sterile needles and syringes. An injection drug user infected with HIV can cause a cascade of new infections in many other individuals, not only through sharing of injection equipment, but also through sexual and perinatal transmission.
Needle exchange programs, in which used needles are exchanged for new, sterile ones, are one level of response to this crisis in some communities. They have been implemented in many countries (including France, the Netherlands, Great Britain, Australia, and Canada) as part of a more comprehensive public health effort to reduce the spread of HIV and other blood-borne infections among drug users, their sexual partners, and the general population. In the United States, approximately 75 needle exchange programs have been initiated in 55 cities, although many are small and the programs have not been endorsed by the federal government as a viable intervention for the prevention of AIDS. Obstacles to this approach include legal, economic, and behavioral factors.
For injection drug users who cannot or will not stop injecting drugs, the once-only use of sterile needles and syringes remains the safest, most effective approach for limiting HIV transmission. However, with significant legal impediments to syringe availability, bleach distribution programs were conceived as a means for injection drug users to disinfect needles and syringes between use. If properly used, bleach is effective in the disinfection of HIV and other pathogens—but the effectiveness of bleach as used by injection drug users under street conditions has not been optimal.
The use of federal funds to support needle exchange programs has been specifically prohibited or restricted by the language contained in a series of statutes enacted by Congress since 1988. The ban on federal support remains in effect ''… unless the Surgeon General of the United States determines that such programs are effective in preventing the spread of HIV and do not encourage the use of illegal drugs." This current prohibition applies regardless of whether the programs operating in individual states are legally authorized. As a result, needle exchange programs in communities across the country cannot use federal funds to support services involving the provision of sterile needles, but are limited in their funding to state, municipal, and private sources.

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach
THE PANEL'S CHARGE
At the request of Congress, the Panel on Needle Exchange and Bleach Distribution Programs was established by the National Research Council/Institute of Medicine, with support from the National Institute on Drug Abuse. The panel was asked to undertake a study to determine the effectiveness of needle exchange and bleach distribution programs. The panel's charge is as follows:
The panel will gather and analyze the relevant research regarding the effect of such programs on rates of drug use, the behavior of drug users, and the spread of AIDS and other diseases, such as hepatitis, among intravenous drug users and their partners. In addition, the panel will examine closely related issues of importance to the research and service communities, such as the characteristics associated with effective exchange programs, and will provide recommendations for future research directions and methods applicable to the evaluation of syringe exchange and bleach programs. In the latter task, the study will identify the relevant evaluation hypotheses and delineate the most appropriate methodologies for testing such hypotheses. The panel is authorized, but not committed, to assess the potential risks and benefits associated with the implementation of such programs if it judges the data adequate to make such an assessment.
SCIENTIFIC ASSESSMENT OF PROGRAM EFFECTIVENESS
To examine the context that frames needle exchange and bleach distribution programs, the panel assessed a wide range of studies concerning the magnitude and severity of injection drug use; HIV infection among injection drug users and their partners; and the effects of needle exchange and bleach distribution programs on drug use, HIV risk behaviors, and the spread of HIV/AIDS.
The studies that examine needle exchange and bleach distribution programs have various limitations, including inadequate samples, sample attrition, improper controls, problematic measures, and incomplete analyses. Nevertheless, the limitations of individual studies do not necessarily preclude us from being able to reach scientifically valid conclusions based on the entire body of literature available . The situation resembles the exploration of the relationship between cigarette smoking and lung cancer; virtually every individual study was vulnerable to some particular objection, yet collectively those studies justified a compelling conclusion.
It was essential for the panel first to distinguish between studies of high

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quality and those of lesser quality, and then to weigh the credibility of the findings according to their completeness and soundness. Using this approach, the panel based its conclusions on the pattern of evidence provided by a set of high-quality studies, rather than relying on the preponderance of evidence across less scientifically sound studies.
Needle Exchange
On the basis of its review of the scientific evidence, the panel concludes:
Needle exchange programs increase the availability of sterile injection equipment. For the participants in a needle exchange program, the fraction of needles in circulation that are contaminated is lowered by this increased availability. This amounts to a reduction in an important risk factor for HIV transmission.
The lower the fraction of needles in circulation that are contaminated, the lower the risk of new HIV infections.
The act of giving a needle to an injection drug user has a powerful symbolism that has sparked fears about the potential negative effects of needle exchange programs. However:
There is no credible evidence to date that drug use is increased among participants as a result of programs that provide legal access to sterile equipment.
The available scientific literature provides evidence based on self-reports that needle exchange programs do not increase the frequency of injection among program participants and do not increase the number of new initiates to injection drug use.
The available scientific literature provides evidence that needle exchange programs have public support, depending on locality, and that public support tends to increase over time.
Needle exchange programs should be regarded as an effective component of a comprehensive strategy to prevent infectious disease.
Bleach Distribution
Although HIV has been shown to be susceptible to inactivation by bleach under idealized conditions in the laboratory, epidemiologic studies have not demonstrated a significant protective effect against HIV infection for injection drug users who report consistent use of bleach to decontaminate

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach
needles and syringes previously used by others (see Chapter 6). Consequently, substantial uncertainty now exists among public health officials, laboratory scientists, community outreach workers, and injection drug users concerning the value of bleach disinfection as a public health intervention. Additional investigation into optimizing disinfection methods is clearly necessary.
The panel concludes:
Bleach, if used according to the recommendations of the Centers for Disease Control and Prevention, the National Institute on Drug Abuse, and the Center for Substance Abuse Treatment (see Chapter 6 for a detailed discussion of these recommendations), is likely to be an effective HIV prevention strategy for injection drug users who share needles and syringes.
Concerted efforts are essential to increase the awareness of injection drug users of the importance of disinfecting shared injection equipment and the importance of following the appropriate procedures.
Bleach use is clearly an intervention to be used when injection drug users have no safer alternatives.
Health research funding agencies (e.g., the National Institutes of Health, the Centers for Disease Control and Prevention, and the Agency for Health Care Policy and Research) should support research directed toward identifying the simplest to use and most effective disinfection strategies, employing agents that are readily available to injection drug users.
COMMUNITY AND LEGAL FACTORS
In policy decisions about needle exchange and bleach distribution programs, the scientific evidence on whether the behaviors of injection drug users change and the rates at which new infections are reduced are but one dimension of an immensely complex issue. These AIDS prevention programs, in different environments, face various levels of community support, different levels of HIV prevalence1 in the local population of injection drug users, and operate within different legal environments. And so the scientific issues cannot be viewed in isolation but must be considered along with these other factors.
A range of views about needle exchange programs has been expressed by various groups, including racial and ethnic minority representatives, law enforcement officials, pharmacists, and drug treatment providers. Specific community concerns range from fears that such programs will worsen already severe drug abuse problems and elevate extant high levels of crime to concerns that such programs promote immoral activities. Although there is much variety among the views of different groups, all share the concern that

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach
handing out sterile injection equipment or bleach bottles to injection drug users does not address the underlying problems associated with drug abuse.
The high levels of concern about potential negative effects of needle exchange and bleach distribution programs cannot be ignored, despite the paucity of evidence supporting them. Furthermore, the long-term effects of these programs on the level of illicit drug use in communities are not yet known. Communities experiencing high levels of drug use and addiction, AIDS, crime, and poverty may well resent the institution of needle exchange and bleach distribution programs, seeing them as a wholly inadequate response to the underlying problems associated with drug abuse and perceiving that they do more harm than good. The panel urges that local community members (e.g., police, church, treatment providers, pharmacists, local public health authorities) should be involved in determining whether such programs should be implemented locally and how they should be institutionalized.
The legal environment is another, very different factor impinging on needle exchange and bleach distribution programs. On the basis of its review of the legal circumstances in which these programs operate, the panel concludes:
Any marked increase in the supply of sterile needles to injection drug users above current levels through pharmacy sales is likely to call for new measures to ensure the safe disposal of used needles. Whereas this problem has been solved in other countries (e.g., Australia provides special containers in public places that allow for proper disposal of used syringes, as well as individual returnable containers for used syringes), it is important to design good solutions to the disposal issue in the United States now.
Laws that make it a criminal offense to possess injection equipment (paraphernalia laws) were designed to decrease the prevalence of injection drug abuse, but they also inhibit users from carrying their own supply of needles and thus unwittingly contribute to the sharing of contaminated ones.
Laws requiring a prescription for the purchase of new needles and syringes (prescription laws) constrain the availability of sterile injection equipment and thus promote the sharing of contaminated equipment.
RECOMMENDED COURSE OF ACTION
The panel concludes that well-implemented needle exchange programs can be effective in preventing the spread of HIV and do not increase the use of illegal drugs. Hence, we recommend that:

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The Surgeon General make the determination called for in P.L. 102-394, section 514, 1993, necessary to rescind the present prohibition against applying any federal funds to support needle exchange programs.
Observe that the panel does not recommend a mandated national program of needle exchange and bleach distribution programs. As documented in this report, regional variations in the prevalence of HIV infection, the extent and kind of drug use, the presence of other AIDS programs, operational characteristics of existing needle exchange programs, and the attitudes and needs of local communities all influence the potential effects of needle exchange programs and militate against such a mandate. The recommendation is to allow communities that desire such programs to institute them, using resources at their disposal and unencumbered by the specific funding handicap that is now in place.
The panel further recommends that:
A better monitoring system should be established for assessing long-term societal changes in drug use at the community level due to needle exchange programs.
The Assistant Secretary for Health should charge appropriate agencies (i.e., the National Institutes of Health and the Centers for Disease Control and Prevention), in consultation with academic departments of epidemiology, to develop more effective surveillance of drug use, particularly for local areas. The data collected should move beyond gross prevalence estimation of drug use and toward detailed information about users. This should include data on behavioral dynamics (e.g., pattern of drug use, sharing of drugs and drug paraphernalia, social context of drug use) by drugs of choice, routes of administration for each, and the flow of injection drug users into and out of drug treatment programs.
Given the serious public health threat associated with HIV infection among injection drug users, their sexual partners, and offspring, the Assistant Secretary for Health should ensure that AIDS prevention efforts targeted to injection drug users are expanded specifically to include behavioral interventions in order to limit the further spread of HIV infection.
The Assistant Secretary for Health should cause the disposal issue to be studied and appropriate means of needle disposal to be developed. A task force should be appointed and should include health safety specialists, infectious disease specialists, injection drug use researchers, and community representatives/civic leaders.
Legislative bodies should remove legal sanctions for the possession of injection paraphernalia.

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Appropriate legislative bodies should repeal laws in the nine states that require a prescription in order to purchase injection equipment.
These recommendations must be viewed in the overall context of the drug epidemic. Comprehensive responses to this threat to public health are critical: most critical is the expansion of drug treatment to make it more available. Needle exchange programs report increased referrals to drug abuse treatment and, in the few studies that examined this issue, no increase in the number of dirty needles discarded in public places (e.g., parks, streets, alleys). Needle exchange programs should promote HIV prevention not only by providing sterile equipment, but also by means of education, drug treatment referral, and materials, including bleach, alcohol pads, and condoms. Moreover, needle exchange and bleach distribution programs should make special efforts to reach and retain hard-to-reach subgroups of injection drug users, such as young injection drug users and women.
Incremental funds for needle exchange programs and other AIDS prevention strategies should be appropriated but should not be taken from resources now supporting drug treatment programs. Such a diversion of funds would be unwise because drug treatment programs have been shown to be effective in treating the underlying disorder of drug abuse and can be effective in curtailing HIV risk behaviors. Moreover, for many program participants, needle exchange and bleach distribution programs have been found to serve as a bridge to drug treatment for many needle exchange program participants. Indeed, the appropriate legislative bodies should enact legislation (and should appropriate monies) to increase drug treatment capacity. In this context, both needle exchange and bleach distribution programs should be regarded as strategies for public health promotion and disease prevention.
NOTE
1.
Prevalence denotes the proportion of a population that is currently (or at a specified point in time) infected. Incidence denotes the rate of occurrence of new cases of infection per unit of time.